Dialyzer cartridge and method for its manufacture

ABSTRACT

A dialyzer with a housing includes a pair of inflow and outflow pipes for blood and dialysis solution, and a tubular ring body formed from a plurality of hollow filaments joined to one another at their ends and positioned in the housing such that one pair of the pipes is in communicating relationship with open ends of the hollow filaments and the other pair of the pipes communicates with the interstices between adjacent filament forming said tubular ring body. The invention also provides a dialyzer cartridge and a method of manufacturing such cartridge.

BACKGROUND OF THE INVENTION

The invention relates to a dialyser, in particular for haemodialysis,which comprises a housing with inflow and outflow pipes for blood anddialysis solution and open hollow filaments arranged in the housing andjoined to one another at their ends, as well as to a dialyser cartridge,as well as a method for the manufacture of such a dialyser.

Haemodialysis requires a membrane of large surface area, some 1-1.5 m²in size and 10-20 μm thick, of a material capable of acting as adialytic permeable membrane, for example, cellulose acetate,polyacrylonitrile and similar materials are capable to act as separatinglayer between the blood and the suitably composed dialysis solution. Themembrane is relatively easily permeable for water and low molecularweight constituents of the blood, including also substances contained inurine. High molecular weight and corpuscular constituents are howeveralmost completely retained.

Under the term dialysers for haemodialysis can be recognised spool orcoil dialysers, plate dialysers and also capillary or hollow filamentdialysers, in which the membrane is formed from a large number (e.g.10,000) of hollow filaments having a diameter of about 150 μm. In thehitherto usual arrangement the hollow filaments are collected into aloose bundle of parallel filaments and arranged in a cylindricalhousing. The ends of the bundle of hollow filaments are sealed off andpacked against the housing. The inflow and outflow of the blood streamis effected by connecting pieces screwed onto the ends of the housing.The dialysis solution flows, in countercurrent, along the outside of thecapillaries or hollow filaments, inflow and outflow occurring vialateral connections in the vicinity of the ends of the housing.

In designing a hollow filament dialyser great efforts are made toachieve as great an effectiveness as possible, i.e. a flow distributionas uniform as possible is necessary in order to fully utilize themembrane surface. High flow velocities are also desirable since thisreduces the diffusion resistance in the blood and dialysis solution.Furthermore, the blood filling volume should be as small as possible andthe blood flow resistance should be low. A hollow filament dialyser inprinciple provides the necessary prerequisites in order to meet theserequirements.

OBJECTS OF THE INVENTION

In view of the above, it is the aim of the invention to achieve thefollowing objects, singly or in combination:

to provide a dialyser of the afore-mentioned type which optimally meetsthe above requirements and which furthermore can be manufactured in anadvantageous manner;

to provide a dialyser in which the hollow filaments are in the form of aring with the inflow and outflow of the medium flowing in theinterstices from the middle thereof;

to provide a dialyser cartridge that is replaceable within a housing,having inflow and outflow pipes associated therewith especially forblood dialysis; and

to provide a method for manufacturing of a dialyser cartridge and/orhousing.

SUMMARY OF THE INVENTION

In order to solve this problem the invention provides a dialyser inwhich the hollow filaments are arranged in the form of a ring and theinflow and outflow of the medium flowing in the interstices between thehollow filament pieces takes place from the middle. The flow conditionsare thereby favorably influenced, and in addition this also provides thepossibility of manufacturing the unit consisting of hollow filaments ina particularly convenient manner.

A further embodiment of the invention accordingly proposes that thehollow filaments are wound on the core and that the ends of the woundhollow filament body are then impregnated with a cast resin and the endregions are cut off, after solidification, in such a way that the frontsurfaces of the individual hollow filament pieces are open.

In this connection, the hollow filaments can be wound inclined orparallel to the axis of the core, winding being carried out with devicesknown per se.

BRIEF FIGURE DESCRIPTION

In order that the invention may be clearly understood, it will now bedescribed, by way of example, with reference to the accompanyingdrawings, wherein:

FIG. 1 is a sectional view through a dialyser according to theinvention;

FIG. 2 is a perspective view of a hollow filament body with the hollowfilament windings inclined to the core axis; and

FIG. 3 is a perspective view of a hollow filament body with windingsparallel to the core axis.

DETAILED DESCRIPTION OF PREFERRED EXAMPLE EMBODIMENTS

Referring now to the drawings dialyser 1 according to the invention, isillustrated in FIG. 1, and consists of a two-part housing 2 in which ahollow filament body or cartridge 3 is located. The hollow filament bodyconsists of a core 4, on which a body or hollow filament 5 consists ofcellulose acetate or polyacrylonitrile is wound in accordance with FIG.2 or 3.

The core 4 may be tubular having an outer wall or surface 4a and aninner wall or surface 4b with at least one radially extending separatingwall 6 there between, as well as several passage openings 9 distributedon the periphery between the outer wall 4a and the inner wall 4b,adjacent the two ends 7 and 8 of the core 4. The wall 6 separates ordivides the core 4 into a pair of chambers 6a that are sealed from eachother by the separating wall 6. The two halves or sections 10 and 11 ofthe housing 2 each have together with the tubular shaped core 4 analigned inflow conduit or pipe 12 and outflow conduit or pipe 13. Thepair or set of pipes 12 and 13 may be in axial alignment with each otherand having a terminal end 12a and 13a respectively. Each pipe 12 and 13may extend into an enlarged passage 12b and 13b respectively, which arein alignment with the chambers 6a to provide a proper flow of fluidtherethrough. Each half 10 and 11 further has another pair or set ofpipes consisting of an inflow pipe 14 and outflow pipe 15 which open outinto a guide channel 16 and 17 in the interior of the halves 10 and 11of the housing 2. The width of the two channels 16 and 17 preferablycorresponds to the layer of hollow filament pieces 18 arranged in theform of a ring on the core 4. The inflow pipe 14 has an outer end 14a,and the outflow pipe 15 has an outer end 15a. The inflow pipe 14 andoutflow pipe 15 are provided in non-aligned relationship with respect toeach other to provide the necessary flow length for the dialysis fluid.

Like the cylindrical core 4, the hollow filament body 3 also has acircular cross-section. A jacket 19 is arranged on the circumference ofthe hollow filament body 3, which not only holds together the externalhollow filament pieces 18 but also serves for sealing purposes. Thejacket 19 may extend the same axial length as the core 4 and coincidewith the ends 7 and 8 thereof. As illustrated in FIG. 1 the guidechannels 16 and 17 each include an inner edge or wall 16a and 17a thatengages the ends 7 and 8 respectively, of the core 4 as well as each endof jacket 19. The core 4 and jacket 19 may be in co-axial alignment witheach other.

The manufacture of the hollow filament body is carried out in accordancewith FIGS. 2 and 3 in such a way that the hollow filament 5 is wound onthe core 4 with an arbitrary number of windings 20, 21 and 22, thewinding being performed so that the windings are either inclined orparallel to the longitudinal axis or plane of the core 4. During thewinding procedure the hollow filament 5 is led back and forth so thatafter a certain angle of rotation of the winding device carrying thecore 4, the said filament moves from one edge to the other edge. Acompact or a lightly wound hollow filament body is thus obtaineddepending on the angle of inclination.

The ends of the hollow filament body 3 wound in this manner are thenimpregnated with a cast resin so that all interstices are filled and thewindings of the hollow filaments 5 are firmly embedded. In a followingoperation the outermost end regions of the hollow filament body 3impregnated by the cast resin are cut off along the dotted lines 23 and24 in FIG. 2, with the result that hollow filament pieces 18 roughlycorresponding to the length of the core 4 are formed, which are open andfreely accessible at their front faces for a flow of fluid through thehollow filament pieces 18.

In the case of the hollow filament body 3 shown in FIG. 3, the hollowfilament 5 is wound over the circumference and the front sides of thecore 4 so that the hollow filament pieces 18 lie on the circumference ofthe core approximately parallel to the axis thereof.

During the winding the core 4 is slowly rotated about its longitudinalaxis, which is at right angles to the winding axis. The angulardisplacement depends on the relationship between winding rate and therotational velocity of the hollow filament body. The required distanceor spacing between the hollow filament pieces 18 can be achieved by thesimultaneous applying or winding of foil strips 25 and 26, which arewound in the direction of the circumference as can be seen from FIG. 3.

When the hollow filament body 3 has been impregnated with cast resin,hardened, and then cut at its edge or end regions, after the windingprocedure, the jacket 19 is applied, following which the hollow filamentbody 3 can be inserted into the housing 2 consisting of practicallyequal sections of halves 10 and 11. After insertion, the two halves 10and 11 or the housing are securely connected to one another in theirflange region 27 and 28 in a conventional manner.

The dialysis solution enters the dialyser through the centrally arrangedinflow pipe 12 in the direction of arrow 32, and first of all passesinto one half, or chamber 6a, of the tube-shaped core 4, from which itthen flows through the passage openings 9 in the direction of arrows 34,and splits up in the interstices between the hollow filament pieces 18.After the dialysis solution has flowed through the hollow filament body3, it reenters the core 4 through the passage opening 9, in thedirection of arrows 36, at the other end thereof into chamber 6a andthen flows directly to the outflow pipe 13, in the direction of arrow38.

The blood flows through the dialyser 1 in the opposite direction. Itenters through the inflow pipe 14, in the direction of arrow 40 whichopens out into the guide channel 16. From there the blood is distributedthrough the hollow filament pieces 18 from which it flows into the guidechannel 17 in the other half 10 of the housing, which channel 17collects the blood and passes it to the outflow pipe 15 in the directionof arrow 42.

FIG. 1 clearly illustrates the sealing function of the jacket 19,against the walls 16a and 17a which prevents any bypass for the dialysissolution parallel to the hollow filament pieces 18 and into the chamber6a, or passages 12b or 13b.

A further prerequisite for satisfactory operation is that the endregions 29 and 30 of the hollow filament body 3, which are sealed with acast resin, are absolutely tight and impermeable since otherwisedialysis solution can pass into the two guide channels 16 and 17. Theposition of the passage openings 9 is chosen so that they areimmediately adjacent to the end regions 29 and 30 impregnated with castresin. In this manner the spacing between each hollow filament 18 issealed preventing the escape from each end region 29 and 30, and yetpermitting the flow of fluid through the individual filament pieces 18.

The dialysis solution or medium is distributed very rapidly over thewhole cross-section of the circularly arranged hollow filament pieces 18by virtue of the feed of dialysis solution from the centrally arrangedcore 4 into the interstices between the hollow filament pieces 18 whichare in communicating relationship with inflow and outflow pipes 12 and13. The transition zone from a uniformly "flushed" cross-section to a"non-flushed" cross-section is very short at the inflow and outflow,which is accompanied by an increase in the exchange efficiency onaccount of the better utilization of the incorporated hollow filamentsurface. This can be fully exploited by incorporating a correspondinglysmaller amount of hollow filament material in the dialyser, any increasein efficiency being relinquished, and in addition the flow resistance onthe blood side can be markedly reduced if the number of hollow filamentsis increased and their length is reduced, the total surface arearemaining the same. This provides one of the conditions in haemodialysisfor driving the blood circulation outside the body without the use ofblood pumps, the natural arterial-venous pressure drop being utilized.The invention is not limited to the examples of the embodimentsillustrated in the figures, and indeed alterations can be carried outwithout departing from the basic ideas of the invention. Thus, forexample, it is also possible to provide appropriate separating wallsinstead of the separating wall 6 immediately adjacent to the passageopenings 9, so that the dialysis solution passes into the interior ofthe hollow filament body 3 via the shortest pathway. Furthermore, it mayalso be convenient if the manufacturing procedure described above isaltered and the jacket 19 is applied before the ends of the hollow fiberbody are impregnated with cast resin.

Although the invention has been described with reference to specificexample embodiments, it is to be understood, that it is intended tocover all modifications and equivalents within the scope of the appendedclaims.

What is claimed is:
 1. A dialyser comprising housing means having alongitudinal axis and a central plane of symmetry extendingperpendicularly to said longitudinal axis, said housing means includingfirst and second housing members each of which has a substantiallymirror-symmetrical shape relative to the respective other housing memberand relative to said plane of symmetry, each housing member having anopen end portion facing said plane of symmetry and means for connectingthe open end portions of the two housing members to each other, eachhousing member further comprising a port section opposite said open endportion, each port section comprising first central port means arrangedsubstantially concentrically relative to said longitudinal axis and acentral cavity smoothly merging into said central port means and openopposite the respective first port means, each port section furthercomprising second port means located radially outwardly of said first,central port means and a ring cavity surrounding said central cavity andsmoothly merging into the respective second port means, said ring cavityalso being open toward said open end portion of the respective housingmember, dialyser cartridge means in said housing means, said dialysercartridge means comprising hollow tubular core means with a wall thereindividing said hollow tubular core means into two cavities extendingcoaxially relative to said longitudinal axis and substantually inregister with the respective one of said central cavities in thecorresponding port section, hollow filaments wound on said hollow,tubular core means, said hollow filaments having open ends, meansbonding said open ends of said filaments to each other so as to closethe spaces between the filaments adjacent the open ends and to form aring body of filaments directly around said hollow tubular core means,said ring body of filaments having interstices between adjacentfilaments intermediate said bonding means, radially extending holes insaid hollow, tubular core means to provide for a smooth flowcommunication between said first port means through said centralcavities, through said radially extending holes, and through saidinterstices between adjacent filaments, said open ends of said filamentring body extending substantially in register with the respective one ofsaid ring cavities to provide for a further smooth flow communicationbetween said second port means through said ring cavities andlongitudinally through said hollow filaments.
 2. The dialyser of claim1, further comprising jacket means surrounding said filaments on saidtubular core means.
 3. The dialyser of claim 1, wherein said hollowfilaments are directly wound on said hollow, tubular core to formwinding sections having a curved shape and extending in planes slantingat an angle relative to said longitudinal central axis, said angle beingsuch that said open ends of said filaments face the respective ringcavity (FIG. 2).
 4. The dialyser of claim 1, wherein said hollowfilaments are directly wound on said hollow tubular core to form windingsections having a substantially rectangular shape initially havingaxially and radially extending portions, the latter having been cut offso that said open ends of said filaments face the respective ringcavity, (FIG. 3).
 5. The dialyser of claim 1, wherein said radiallyextending holes in said hollow, tubular core means are located near theouter ends of said hollow, tubular core means away from said wall insaid hollow tubular core means whereby flow of liquid extendssubstantially radially adjacent said bonding means into and out of saidinterstices and substantially axially through said intersticesintermediate said holes in said hollow tubular core means.
 6. Thedialyser of claim 5, wherein said wall is located substantially in saidplane of symmetry.
 7. The dialyser of claim 1, further comprisingshoulder means in said port sections, said shoulder means contactingsaid hollow, tubular core means in a sealing manner. .Iadd.
 8. Adialyzer comprising housing means having a longitudinal axis and acentral plane of symmetry extending perpendicularly to said longitudinalaxis, said housing means including first and second housing members eachof which has a substantially symmetrical shape relative to therespective other housing member and relative to said plane of symmetry,each housing member having an open end portion facing said plane ofsymmetry and means for connecting the open end portions of the twohousing members, each housing member further comprising a port sectionopposite said open end portion, each port section comprising firstcentral port means arranged substantially concentrically relative tosaid longitudinal axis and a central cavity coupled into said centralport means, each port section further comprising second port meanslocated radially outwardly of said first, central port means and a ringcavity surrounding said central cavity and smoothly merging into therespective second port means, said ring cavity being open toward saidopen end portion of the respective housing member, hollow filament meansin said housing means, core means extending coaxially relative to saidlongitudinal axis and between the respective central cavities in thecorresponding port sections, said hollow filament means being held onsaid core means, said hollow filament means having open ends, meansbonding said open ends of said hollow filaments to one another so as toclose the spaces between the filaments adjacent the open ends and toform a ring body of filaments around said core means, said ring body offilaments having interstices between adjacent filaments intermediatesaid bonding means, radially directed passage openings from the centralcavities at the ends of the core means to provide a continuouscommunication between said first port means through said centralcavities, through said radially directed passage openings and throughsaid interstices between adjacent filaments, said core blocking any flowdirectly between said central cavities, said open ends of said filamentring body extending substantially in register with the respective one ofsaid ring cavities to provide for continuous smooth flow communicationbetween said second port means through said ring cavities andlongitudinally through said hollow filaments. .Iaddend..Iadd.
 9. Thedialyzer of claim 8, wherein said means for connecting the open endportions of the two housing members comprise sealing jacket means (19)surrounding said fiber bundle means. .Iaddend..Iadd.
 10. The dialyzer ofclaim 8, wherein said first or second housing members comprise flangedenclosure portions enclosing said dialyzer and abutting against eachother in connecting relationship. .Iaddend..Iadd.
 11. A dialyzercomprising elongated housing means having a longitudinal axis, saidhousing means including outer jacket sealing means extending coaxiallyto said longitudinal axis, central core means extending coaxially withinthe outer jacket sealing means, said outer jacket sealing means andcentral core means defining therebetween an annular space extendingalong the longitudinal axis of the housing, first and second housing endmembers engaging the coaxial outer jacket sealing means and central coremeans at each end of the housing means; hollow filament means comprisinghollow filaments positioned about said central core means andsubstantially occupying the annular space between the outer jacketsealing means and the central core means, said hollow filaments havingopen ends facing the respective end member at both ends of said housingmeans; means bonding the open ends of said filaments to each other toclose spaces between the filaments at each end of said housing means,thereby forming substantially a ring body of open ended filaments aroundthe core means, whereby the open filament ends face the housing endmembers; said housing end members defining at each end of the housingmeans a ring cavity facing the open filament ends, said end memberscomprising peripheral port means smoothly merging into the ring cavitymeans for continuous smooth flow communication of fluid from saidperipheral port means through said ring cavity and into the hollowfilaments of the bundle through the open filament ends; said hollowfilament means having interstices between adjacent filaments extendingsubstantially the entire length of the filament bundle intermediate thebonding means at each end; said first and second housing end membersfurther defining in combination with said central core means, centralcavity means at each end of said housing means, said end memberscomprising central port means opening into said central cavity means;said central core means comprising flow blocking means intermediate theends thereof to prevent passage of fluid through said central core meansfrom one end to the other; said central core means further comprisingopening means distributed around the periphery of said core means ateach end of the core means for directing fluid from the central cavityradially outwardly into the interstices between said filaments at oneend of the filaments and for receiving fluid from the interstices at theother end of the filaments; said outer jacket sealing means and centralcore means thereby confining the flow of fluid, received through thecentral port means and distributed radially into the interstices of thefilaments, axially along the interstices through substantially theentire length of the filaments between the bonding means..Iaddend..Iadd.
 12. The dialyzer of claim 11, wherein said outer jacketsealing means comprises elongated cylindrical wall means and whereinsaid central core means comprises coaxial cylindrical core means..Iaddend..Iadd.
 13. The dialyzer of claim 11, wherein said central coremeans comprises a tubular core and wherein said separating means forsealing the tubular core means to prevent passage of fluid through thecore comprises wall means across the tubular core intermediate saidopening means at each end of core means. .Iaddend. .Iadd.
 14. A dialyzercomprising housing means (10, 11), a first set of ports including inflowport means (14) for blood in said housing means and outflow port means(15) for blood in said housing means, a second set of ports includingdialysis liquid inflow port means (12) in said housing means anddialysis outflow port means (13) in said housing means, tubular coremeans (4) in said housing means to provide an annular space between saidhousing means and said core means (4), hollow filament means (3, 18)having open filament ends, sealing and bonding means (29, 30)operatively bonding the hollow filament means (3, 18) to one anotheradjacent said open ends, said hollow filament means occupying saidannular space, first flow communication means in said housing means (16,17) for providing flow communication into and out of said open filamentends and the respective one of said port sets arranged at each end ofsaid hollow filament means, interstices extending between said hollowfilament means substantially all along said hollow filament meansbetween said bonding means (29, 30), second flow communication means (9)in said core means (4) for providing flow communication between saidinterstices and said second set of ports, said second flow communicationmeans consisting of first and second passage openings (9) extendingradially outwardly through said core means (4) and located onlysubstantially directly adjacent to each of said bonding means (29, 30),and separation means (6) in said core means (4) for closing off saidfirst passage openings (9) from said second passage openings (9) exceptthrough said interstices whereby a liquid flowing from said inflow portmeans to said outflow port means of said second set of ports is forcedto flow through said interstices substantially along the entireeffective length of said filament means between said first and secondpassage openings, for optimally using the available interface surfaceformed by said hollow filament means. .Iaddend..Iadd.
 15. The dialyzerof claim 14, further comprising jacket means (19) surrounding saidhollow filament means and said core means in said housing means..Iaddend.